Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

Inclusion Criteria:

• Biopsy proven adenocarcinoma of the rectum
• Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
• Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
• Karnofsky Performance Status at >60
• Laboratory criteria:
• Absolute neutrophil count >= 1.5 K
• Platelets >= 100 K
• Total Bilirubin <= 2.0;
• SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
• Creatinine < 2.0
• Hemoglobin >= 8.0
• Informed consent signed
• Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
• Estimated longevity at least 12 months
• Patients with distant metastatic disease will be eligible if they satisfy all other conditions

Exclusion Criteria:

• Pregnant women, children < 18 years, or patients unable to give informed consent
• Patients with a past history of pelvic radiotherapy.
• Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
• Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
• Prior chemotherapy for colorectal cancer.
• Grade >= 2 peripheral neuropathy
• Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy